DCGI to ramp up facility audits for medical device makers; test-license waivers expected

The DCGI announced it will significantly increase facility audits for medical device makers moving forward, while considering test-license waivers, after issuing 30,000 product licences over the past two years, per ET HealthWorld. Healthtech and device manufacturers should accelerate compliance infrastructure—audit readiness will become a competitive moat, and those who can demonstrate clean audits will capture market share as smaller players get de-listed.

Source: ET HealthWorld ↗